Clinical Supply Agreement Template for Singapore

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Key Requirements PROMPT example:

Clinical Supply Agreement

"Need a Clinical Supply Agreement for a Phase II oncology trial where our Singapore-based pharmaceutical company will receive drug supplies from a manufacturer in Germany, with first delivery required by March 2025 and specific temperature control requirements."

Document background
The Clinical Supply Agreement is essential for organizations conducting clinical trials in Singapore, establishing the framework for the supply of investigational products and related materials. This agreement type is crucial for ensuring compliance with Singapore's strict regulatory environment, including HSA guidelines and Good Manufacturing Practice requirements. It typically covers quality standards, manufacturing processes, testing procedures, storage conditions, and delivery specifications, while addressing local regulatory requirements for clinical trial materials.
Suggested Sections

1. Parties: Details of the supplier and recipient entities, including registration numbers and addresses

2. Background: Context of the agreement, including the clinical trial details and purpose of supply

3. Definitions: Key terms used throughout the agreement including Product, Specifications, GMP, Clinical Trial

4. Supply Obligations: Core obligations regarding the supply of clinical materials, including quantities, timelines

5. Quality Requirements: GMP compliance, specifications, testing requirements

6. Delivery and Storage: Delivery terms, storage conditions, handling requirements

7. Regulatory Compliance: Compliance with applicable laws, permits, licenses

8. Payment Terms: Pricing, payment schedule, invoicing requirements

9. Confidentiality: Protection of confidential information exchanged

10. Term and Termination: Duration of agreement and termination provisions

Optional Sections

1. Manufacturing Change Control: Process for managing manufacturing changes when supplier is manufacturing the product

2. Technology Transfer: Terms for transfer of manufacturing technology when manufacturing process needs to be transferred

3. Safety Reporting: Procedures for adverse event reporting when supplier has direct involvement in safety monitoring

4. Insurance: Insurance requirements and coverage when specific insurance coverage is required

Suggested Schedules

1. Product Specifications: Detailed technical specifications of the clinical supplies

2. Quality Agreement: Detailed quality requirements and responsibilities

3. Pricing Schedule: Detailed pricing information and structure

4. Supply Schedule: Delivery timeline and quantities

5. Technical Transfer Protocol: Details of technology transfer process if applicable

6. Safety Data Exchange Agreement: Procedures for safety data exchange between parties

7. Storage and Handling Requirements: Detailed storage and handling specifications

Authors

Alex Denne

Head of Growth (Open Source Law) @ Genie AI | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

Relevant legal definitions
Clauses
Industries

Medicines Act (Chapter 176): Primary healthcare legislation governing the regulation of medicinal products, including their manufacture, import, supply, and use in clinical trials in Singapore

Health Products Act: Legislation controlling health products, medical devices, and related matters in Singapore's healthcare system

Medicines (Clinical Trials) Regulations: Specific regulations governing the conduct of clinical trials involving medicines in Singapore

Health Products (Clinical Trials) Regulations: Regulations specifically focused on clinical trials involving health products and medical devices

Singapore Guideline for Good Clinical Practice: Guidelines ensuring ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials

Human Biomedical Research Act (HBRA): Legislation governing human biomedical research, ensuring ethical conduct and participant protection

Personal Data Protection Act (PDPA): Framework for data protection and privacy, including handling of personal and medical information

HSA Guidelines: Health Sciences Authority's comprehensive guidelines for clinical trials, product safety, and quality standards

Good Manufacturing Practice (GMP): Standards ensuring consistent production and quality control of medical products

Good Distribution Practice (GDP): Guidelines for proper distribution practices of medical products and clinical supplies

Singapore Contract Law: General contract law principles governing formation and enforcement of agreements in Singapore

Sale of Goods Act: Legislation governing contracts for the sale and supply of goods

Patents Act: Law protecting intellectual property rights related to inventions and innovations

Trade Secrets Act: Protection of confidential business information and trade secrets

Customs Act: Regulations governing import and export of goods, including clinical supplies

Strategic Goods (Control) Act: Controls on strategic goods, including certain types of medical and pharmaceutical products

ICH Guidelines: International Council for Harmonisation guidelines for pharmaceutical development and clinical trials

WHO Guidelines: World Health Organization's international standards for clinical research and medical products

HSA's Guidance on Clinical Research Materials: Specific guidance on handling, storage, and use of clinical research materials in Singapore

Singapore Medical Council Guidelines: Professional standards and guidelines for medical practitioners involved in clinical trials

Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

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